CA2941232C - Method for purifying immunoglobulin - Google Patents
Method for purifying immunoglobulin Download PDFInfo
- Publication number
- CA2941232C CA2941232C CA2941232A CA2941232A CA2941232C CA 2941232 C CA2941232 C CA 2941232C CA 2941232 A CA2941232 A CA 2941232A CA 2941232 A CA2941232 A CA 2941232A CA 2941232 C CA2941232 C CA 2941232C
- Authority
- CA
- Canada
- Prior art keywords
- exchange chromatography
- immunoglobulin
- fraction
- anion exchange
- cation exchange
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 135
- 102000018358 immunoglobulin Human genes 0.000 title claims abstract description 135
- 238000000034 method Methods 0.000 title claims abstract description 60
- 238000005571 anion exchange chromatography Methods 0.000 claims abstract description 41
- 238000001556 precipitation Methods 0.000 claims abstract description 34
- 238000005277 cation exchange chromatography Methods 0.000 claims abstract description 26
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- 239000002904 solvent Substances 0.000 claims abstract description 16
- 239000003729 cation exchange resin Substances 0.000 claims abstract description 15
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 14
- WWZKQHOCKIZLMA-UHFFFAOYSA-M octanoate Chemical compound CCCCCCCC([O-])=O WWZKQHOCKIZLMA-UHFFFAOYSA-M 0.000 claims abstract description 13
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 12
- 238000010253 intravenous injection Methods 0.000 claims abstract description 11
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- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims description 8
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Applications Claiming Priority (1)
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| PCT/KR2014/002021 WO2015137531A1 (ko) | 2014-03-11 | 2014-03-11 | 면역글로불린의 정제방법 |
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| CA2941232A1 CA2941232A1 (en) | 2015-09-17 |
| CA2941232C true CA2941232C (en) | 2020-08-25 |
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| CA2941232A Active CA2941232C (en) | 2014-03-11 | 2014-03-11 | Method for purifying immunoglobulin |
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| EP (1) | EP3118210B1 (es) |
| KR (1) | KR101917197B1 (es) |
| CN (1) | CN106414476B (es) |
| CA (1) | CA2941232C (es) |
| ES (1) | ES2769783T3 (es) |
| WO (1) | WO2015137531A1 (es) |
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| EP3275897A1 (en) * | 2016-07-27 | 2018-01-31 | Biotest AG | Process for preparing immunoglobulin compositions |
| AU2016231646B2 (en) * | 2016-09-26 | 2021-04-08 | Instituto Grifols, S.A. | Method for the preparation of immunoglobulins |
| KR101941974B1 (ko) * | 2016-11-18 | 2019-01-24 | 주식회사 녹십자 | 혈장 단백질 정제시 fxi의 제거방법 |
| KR102426041B1 (ko) * | 2017-08-01 | 2022-07-29 | 주식회사 녹십자 | 냉동 및 해동 과정을 포함하는 백일해균 유래 단백질 수득 방법 |
| KR20190047376A (ko) * | 2017-10-27 | 2019-05-08 | 주식회사 녹십자 | 개선된 면역글로불린의 정제방법 |
| CN109627329A (zh) * | 2018-12-27 | 2019-04-16 | 成都蓉生药业有限责任公司 | 一种人免疫球蛋白制备时去除和灭活病毒的方法 |
| CN113474360A (zh) | 2019-02-18 | 2021-10-01 | 伊莱利利公司 | 治疗性抗体制剂 |
| CN111471101A (zh) * | 2020-04-13 | 2020-07-31 | 国药集团武汉血液制品有限公司 | 一种去除人免疫球蛋白类制品中残留的IgA的方法 |
| CN111778232B (zh) * | 2020-07-10 | 2022-03-11 | 江苏尤里卡生物科技有限公司 | 一种人尿激酶原料精制过程中去除内毒素的方法 |
| US20240034749A1 (en) * | 2021-02-04 | 2024-02-01 | Green Cross Corporation | Method for purification of hemopexin and haptoglobin |
| KR20230148961A (ko) * | 2022-04-19 | 2023-10-26 | 에스케이플라즈마 주식회사 | 면역글로불린 정제방법 |
| BE1029863B1 (nl) * | 2022-05-10 | 2023-05-12 | Prothya Biosolutions Belgium | WERKWIJZEN VOOR HET PRODUCEREN VAN IMMUNOGLOBULINE G (IgG) PREPARATEN EN/OF OPLOSSINGEN |
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| DE2604759C2 (de) | 1976-02-07 | 1983-06-01 | SCHURA Blutderivate GmbH & Co KG, 4150 Krefeld | Verfahren zur Gewinnung von iv-verträglichen Γglobulinen |
| US4124576A (en) | 1976-12-03 | 1978-11-07 | Coval M L | Method of producing intravenously injectable gamma globulin |
| KR830002739B1 (ko) | 1981-12-05 | 1983-12-10 | 주식회사 녹십자 | 정맥주사용 감마글로블린의 제조방법 |
| US4764369A (en) | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
| EP0659767B2 (de) * | 1993-12-27 | 2002-11-06 | ZLB Bioplasma AG | Verfahren zur Herstellung eines Konzentrates von Anti-D-Immunoglobulin G und pharmazeutische Zusammensetzung, die dieses enthält |
| US6124437A (en) * | 1997-03-19 | 2000-09-26 | Welfide Corporation | Immunoglobulin preparation and preparation process thereof |
| US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| ES2527915T3 (es) * | 1998-06-09 | 2015-02-02 | Csl Behring Ag | Producto de inmunoglobulina G (IgG) líquido |
| PL352910A1 (en) * | 1999-06-15 | 2003-09-22 | Alpha Therapeutic Corporation | Manufacturing method for intravenous immune globulin and resultant product |
| GB0304576D0 (en) * | 2003-02-28 | 2003-04-02 | Lonza Biologics Plc | Protein a chromatography |
| MXPA06008435A (es) * | 2004-01-30 | 2007-05-23 | Suomen Punainen Risti Veripalvelu | Proceso de manufactura de una inmunoglobulina libre de virus. |
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| ES2449148T5 (es) * | 2007-06-01 | 2023-06-14 | Hoffmann La Roche | Purificación de inmunoglobulinas |
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| IL212911A0 (en) * | 2011-05-16 | 2011-07-31 | Omrix Biopharmaceuticals Ltd | Immunoglobulin reduced in thrombogenic contaminants and preparation thereof |
| DE102011105525B4 (de) * | 2011-06-24 | 2015-03-26 | Sartorius Stedim Biotech Gmbh | Verfahren zur Abtrennung von Biopolymer-Aggregaten und Viren aus einem Fluid |
| AR087953A1 (es) * | 2011-08-26 | 2014-04-30 | Baxter Int | Metodo para reducir el potencial tromboembolico de una composicion de inmunoglobulina derivada de plasma |
| KR20150024301A (ko) * | 2012-05-25 | 2015-03-06 | 노파르티스 아게 | 생물학적 치료제 및 구아니딘 또는 구아니딘 유도체를 함유하는 수성 약제학적 조성물 및 당해 조성물을 포함하는 주사제 |
| AU2013203043B2 (en) * | 2013-03-15 | 2016-10-06 | Takeda Pharmaceutical Company Limited | Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs |
| CN105358571B (zh) * | 2013-07-01 | 2019-03-05 | 瑞士杰特贝林生物制品有限公司 | 方法 |
| US10287315B2 (en) * | 2014-03-11 | 2019-05-14 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
| KR101657690B1 (ko) * | 2015-06-05 | 2016-09-19 | 주식회사 녹십자홀딩스 | 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법 |
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2014
- 2014-03-11 ES ES14885344T patent/ES2769783T3/es active Active
- 2014-03-11 CN CN201480078536.3A patent/CN106414476B/zh active Active
- 2014-03-11 EP EP14885344.3A patent/EP3118210B1/en active Active
- 2014-03-11 US US15/123,925 patent/US10414816B2/en active Active
- 2014-03-11 WO PCT/KR2014/002021 patent/WO2015137531A1/ko active Application Filing
- 2014-03-11 CA CA2941232A patent/CA2941232C/en active Active
- 2014-03-11 KR KR1020167024071A patent/KR101917197B1/ko active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| CN106414476B (zh) | 2019-12-31 |
| EP3118210A4 (en) | 2017-11-15 |
| WO2015137531A1 (ko) | 2015-09-17 |
| KR101917197B1 (ko) | 2018-11-09 |
| EP3118210B1 (en) | 2019-11-13 |
| EP3118210A1 (en) | 2017-01-18 |
| ES2769783T3 (es) | 2020-06-29 |
| CN106414476A (zh) | 2017-02-15 |
| US10414816B2 (en) | 2019-09-17 |
| CA2941232A1 (en) | 2015-09-17 |
| KR20160118299A (ko) | 2016-10-11 |
| US20170015732A1 (en) | 2017-01-19 |
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